FDA label f1c6a6bd-50a5-410b-94d4-84abdad23ea9

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
a892a51b-d66c-4b17-be80-9df56f401ea1
SPL ID
f1c6a6bd-50a5-410b-94d4-84abdad23ea9
Version
3
Effective date
2018-03-09
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:01:15

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of dipyridamole USP tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing dipyridamole USP tablets and warfarin therapy to either warfarin alone or warfarin and placebo: Table 1: Adverse Reactions Reported in 2 Heart Valve Replacement Trials DIPYRIDAMOLE TABLETS, USP Adverse Reactions Tablets/Warfarin Placebo/Warfarin Number of patients 147 170 Dizziness 13.6% 8.2% Abdominal distress 6.1% 3.5% Headache 2.3% 0.0% Rash 2.3% 1.1% Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication. When dipyridamole USP tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed. In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.

adverse reactions table

<table ID="_Refid_13861e76-f4f1-4ce2-a261-b7f6ece34" width="100%"> <caption>DIPYRIDAMOLE TABLETS, USP</caption> <col width="33%"/> <col width="33%"/> <col width="33%"/> <thead> <tr> <th align="left" styleCode="Rrule Botrule Toprule " valign="top"> <content styleCode="bold"> Adverse Reactions</content> </th> <th align="left" styleCode="Rrule Botrule Toprule " valign="top"> <content styleCode="bold"> Tablets/Warfarin</content> </th> <th align="left" styleCode="Botrule Lrule Toprule " valign="top"> <content styleCode="bold"> Placebo/Warfarin</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Toprule " valign="top"> <paragraph> Number of patients</paragraph> </td> <td styleCode="Toprule " valign="top"> <paragraph> 147</paragraph> </td> <td styleCode="Toprule " valign="top"> <paragraph> 170</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Dizziness</paragraph> </td> <td valign="top"> <paragraph> 13.6%</paragraph> </td> <td valign="top"> <paragraph> 8.2%</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Abdominal distress</paragraph> </td> <td valign="top"> <paragraph> 6.1%</paragraph> </td> <td valign="top"> <paragraph> 3.5%</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Headache</paragraph> </td> <td valign="top"> <paragraph> 2.3%</paragraph> </td> <td valign="top"> <paragraph> 0.0%</paragraph> </td> </tr> <tr> <td styleCode="Botrule " valign="top"> <paragraph> Rash</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 2.3%</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 1.1%</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.